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Latest Action: 07/31/2008 - Sponsor introductory remarks on measure. (CR S7933-7934)

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. 7/31/2008--Introduced. FDA Food Safety Modernization Act - Amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to: (1) suspend the registration of a food facility; and (2) order a cessation on distribution or recall of food.Directs the Secretary to allocate resources based on the risk profile of food facilities or food.Requires the Secretary and the Secretary of Agriculture to prepare a National Agriculture and Food Defense Strategy.Requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency. Requires the Secretary to: (1) assess fees on domestic food [...]

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Latest Action: 08/01/2008 - Sponsor introductory remarks on measure. (CR S8037-8039)

Bill Text
A bill to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes.

8/1/2008--Introduced.

Sunscreen Labeling Protection Act of 2008 or the SUN Act - Requires the proposed rule issued by the Commissioner of Food and Drugs pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time.

Latest Action: 07/21/2008 - Committee on Appropriations. Original measure reported to Senate by Senator Kohl. With written report No. 110-426.

Bill Text
An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2009, and for other purposes. 7/21/2008--Reported to Senate without amendment.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009 - Title I: Agricultural Programs - Appropriates FY2009 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Office of Homeland Security; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer;[...]

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Latest Action: 07/30/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended.    (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...]

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Latest Action: 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.

Bill Text
To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 3/13/2008--Introduced. Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits [...]

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Latest Action: 06/05/2008 - Mr. Spratt brought up conference report H. Rept. 110-659 for consideration under the provisions of H. Res. 1214.

Bill Text
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013. 5/20/2008--Conference report filed in House.    (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2009, including the appropriate budgetary levels for FY2008 and FY2010-FY2013. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2008-FY2013, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits (on-budget); (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security, U.S. Postal Service discretionary administrative expenses, and specified major functional [...]

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Latest Action: 04/25/2008 - Referred to the Subcommittee on Livestock, Dairy, and Poultry.

Bill Text
To authorize appropriations for the seafood inspection regime of the Food and Drug Administration.

1/29/2008--Introduced.

Authorizes appropriations to implement the seafood inspection regime of the Food and Drug Administration (FDA).

Latest Action: 11/06/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.

11/6/2007--Introduced.

Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements.

Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress.

Latest Action: 11/06/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.

11/6/2007--Introduced.

Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements.

Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress.

Latest Action: 11/05/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. 11/5/2007--Introduced. Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of [...]

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